Pays: Singapour
Langue: anglais
Source: HSA (Health Sciences Authority)
Pregabalin
MEDOCHEMIE SINGAPORE PTE. LTD.
N03AX16
CAPSULE
Pregabalin 75mg
ORAL
Prescription Only
MEDOCHEMIE (FAR EAST) LTD -ORAL FACILITY
ACTIVE
2019-11-25
spc-pregab-caps-2.0 SIRANALEN HARD CAPSULES (Pregabalin) 1. NAME OF THE MEDICINAL PRODUCT Siranalen 75 mg hard capsules Siranalen 150 mg hard capsules Siranalen 300 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 75 mg, 150 mg or 300 mg of pregabalin. Excipient with known effect: lactose monohydrate. Siranalen 300mg also contains carmoisine (E122). Each 75 mg hard capsule contains 8.25 mg lactose monohydrate. Each 150 mg hard capsule contains 16.50 mg lactose monohydrate. Each 300 mg hard capsule contains 33 mg lactose monohydrate and 0.0881mg carmoisine (E122). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Siranalen 75 mg hard capsules: Blue-white hard gelatin capsules size “4” (approximately 14.3mm in length) filled with off white powder. Siranalen 150 mg hard capsules: White-white hard gelatin capsules size “2” (approximately 18.0 mm in length) filled with off white powder. Siranalen 300 mg hard capsules: Maroon-white hard gelatin capsules size “0” (approximately 21.4 mm in length) filled with off white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS_ _ Neuropathic pain Siranalen is i n d i c a t e d f or t h e t r e a t m e nt o f n e u r o pa t h i c p a i n , w h i c h i n c l u d e s d i a b e t i c p e r i p he r a l neuropathy and post-herpetic neuralgia in adults. Epilepsy Siranalen i s i n d i c a t e d a s a d j u n c t i v e t h e r a p y of p a r t i a l seizures, w i t h o r w i t h o u t s e c o n d a r y generalization, in adults. Generalised Anxiety Disorder Siranalen is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults. Fibromyalgia spc-pregab-caps-2.0 Pregabalin is indicated for the management of fibromyalgia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose range is 150 to 600 mg per day given in either two or three divided doses. _Neuropathic pain _ Pregabalin treatment can be started at a dose of 150 mg per day. Based on individual patient response an Lire le document complet
12/2022 Lire le document complet